Guided Imagery: Reducing Stress and Improving Well-being in Pregnant Adolescents
Primary Purpose
Stress, Psychological
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Guided Imagery
Sponsored by
About this trial
This is an interventional supportive care trial for Stress, Psychological
Eligibility Criteria
Inclusion Criteria:
- All pregnant students ages 13-21 enrolled in the alternative education program for parenting teens were eligible to participate
Exclusion Criteria:
- Participants were excluded from the study if they delivered their babies prior to completing four sessions of guided imagery intervention.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Guided Imagery
Arm Description
Participants listened to a pregnancy-specific guided imagery recording on four separate occasions during their pregnancies. Perceived stress was measured immediately pre and post each listening session using the Perceived Stress Measure-9 (PSM-9).
Outcomes
Primary Outcome Measures
Change in Psychological Stress Measure-9 (PSM-9) score
Participants will complete the PSM-9 before and after listening to guided imagery sessions for each of the 4 weekly intervention sessions. The Psychological Stress Measure-9 (PSM-9) is a 9 item questionnaire measuring stress. The original form was published in Canada by Louise Lemyre, PHD and Rejean Tessier, PHD in 1988 and the 9 item was published in 2002. Each response rests on an 8 point likert scale. For general surveys of health and well-being in the workplace, an abridged 9-item version was developed to meet a variety of research needs and applications. The PSM-9 version is used at Hydro-Quebec and Renault (France) as well as in public service, hospitals, community services, and private practice. It has the same psychometric qualities of reliability, validity, and internal consistency (.89) and maintains the same heuristic value for statistics: normality of distribution and responsiveness (Lemyre, Chair, & Lalande-Markon, 2009).
Secondary Outcome Measures
Full Information
NCT ID
NCT02636374
First Posted
December 1, 2015
Last Updated
November 2, 2018
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT02636374
Brief Title
Guided Imagery: Reducing Stress and Improving Well-being in Pregnant Adolescents
Official Title
Guided Imagery: Reducing Stress and Improving Well-being in Pregnant Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the effects of a guided imagery intervention on perceived stress in pregnant adolescents.
Detailed Description
Pregnant adolescents attending a local alternative education program will be subjects of this study. Students will participate in four, 15 minute guided imagery sessions over about a 4-6 week period. They will complete a pregnancy specific stress questionnaire before beginning and after completion of the guided imagery protocol. The students will also complete a short 9-question stress measure before and after each of the individual guided imagery sessions.
The specific aims are:
to evaluate whether a guided imagery intervention reduces perceived stress in pregnant adolescents; and
to evaluate whether a guided imagery intervention enhances well-being in pregnant adolescents.
The hypotheses are that the intervention will reduce perceived stress and enhance well-being in these subjects. The purpose of this study is to assess whether employing a guided imagery intervention with pregnant teens and education will reduce perceived stress levels and improve well-being.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Guided Imagery
Arm Type
Experimental
Arm Description
Participants listened to a pregnancy-specific guided imagery recording on four separate occasions during their pregnancies. Perceived stress was measured immediately pre and post each listening session using the Perceived Stress Measure-9 (PSM-9).
Intervention Type
Behavioral
Intervention Name(s)
Guided Imagery
Intervention Description
A fifteen minute recording of gentle music together with soft talking to guide relaxation.
Primary Outcome Measure Information:
Title
Change in Psychological Stress Measure-9 (PSM-9) score
Description
Participants will complete the PSM-9 before and after listening to guided imagery sessions for each of the 4 weekly intervention sessions. The Psychological Stress Measure-9 (PSM-9) is a 9 item questionnaire measuring stress. The original form was published in Canada by Louise Lemyre, PHD and Rejean Tessier, PHD in 1988 and the 9 item was published in 2002. Each response rests on an 8 point likert scale. For general surveys of health and well-being in the workplace, an abridged 9-item version was developed to meet a variety of research needs and applications. The PSM-9 version is used at Hydro-Quebec and Renault (France) as well as in public service, hospitals, community services, and private practice. It has the same psychometric qualities of reliability, validity, and internal consistency (.89) and maintains the same heuristic value for statistics: normality of distribution and responsiveness (Lemyre, Chair, & Lalande-Markon, 2009).
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All pregnant students ages 13-21 enrolled in the alternative education program for parenting teens were eligible to participate
Exclusion Criteria:
Participants were excluded from the study if they delivered their babies prior to completing four sessions of guided imagery intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karla Ausderau, PhD, OTR/L
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Guided Imagery: Reducing Stress and Improving Well-being in Pregnant Adolescents
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